Container comprising nicotine and the use and manufacture thereof

ABSTRACT

The present invention relates to a container comprising nicotine to be inhaled, which is able to retain and release nicotine, and which comprises a shaped mass of fibers and/or filaments. Further, the present invention relates to the use of said container in an inhaling device for obtaining a quick and/or complete reduction of the urge to smoke or use of tobacco and/or for providing a sense of smoking satisfaction without smoking and to the use of said container in smoking cessation therapy.

[0001] This application hereby claims priority from Swedish patentapplication 0300520-4, filed Feb. 28, 2003 and U.S. provisionalapplication 60/458,159, filed Mar. 27, 2003.

TECHNICAL FIELD

[0002] This invention relates to a container comprising nicotine. Thecontainer is for use in an inhaling device. Such a device is for use innicotine replacement therapy treatment (NRT) and tobacco dependencetreatment.

BACKGROUND OF THE INVENTION

[0003] Tobacco Dependence and Reduction Thereof

[0004] In recent years, with the recognition of the harmful effects oftobacco smoking, there have been numerous campaigns and programs bygovernmental agencies and various health groups and other interestedorganizations to disseminate information about the adverse healtheffects resulting from tobacco smoking. Moreover, and as a result ofthis recognition of the harmful effects, there have been many programsdirected to attempts in reducing smoking incidence.

[0005] Nicotine (C₁₀H₁₄N₂) is an organic compound and is the principalalkaloid of tobacco and it is the chief addictive ingredient in thetobacco used in cigarettes, cigars, snuff and the like. Nicotine is alsoan addictive drug and smokers characteristically display a strongtendency to relapse after having successfully stopped smoking for atime. Nicotine is among the world's most used drug, along with alcoholand caffeine from coffee and tea. It is an addictive poisonous alkaloid.And it is also used as an insecticide. The minimal acute lethal dose ofnicotine in human adults is 40 to 60 mg.

[0006] The main problem with tobacco smoking is its enormousimplications on health. Today it is estimated that smoking-relateddiseases cause some 3-4 million deaths per year. It was estimated, inthe US Surgeon General's 1988 report on The Health Consequences ofSmoking, that in the US alone diseases related to cigarette smokingcause about 300.000 deaths each year. In fact, excessive smoking is nowrecognized as one of the major health problems throughout the world.This grim consequence of tobacco smoking has urged many medicalassociations and health authorities to take very strong actions againstthe use of tobacco.

[0007] Even though tobacco smoking is decreasing in many developedcountries today it is hard to see how the societies could get rid of theworld's second most used drug or even decrease the use thereof.

[0008] The most advantageous thing a heavy smoker can do is tocompletely stop, or at least reduce, his/her smoking. Experience shows,however, that most smokers find it extremely difficult to stop or evento reduce smoking since, mostly, smoking tobacco result in a dependencedisorder or craving. The WHO has in its International Classification ofDisorders a diagnosis called Tobacco Dependence. Others like theAmerican Psychiatric Association call the addiction Nicotine Dependence.It is generally accepted that these difficulties to stop or reducesmoking result from the fact that those heavy smokers are dependent onnicotine. The most important risk factors are, however, substances thatare formed during the combustion of tobacco, such as carbon monoxide,tar products, aldehydes, and hydrocyanic acid.

[0009] Effects of Nicotine

[0010] The administration of nicotine usually provides a pleasantfeeling. The usual method of administration is by intake via the mouth,either by smoking e.g. a cigarette, a cigar or a pipe, or snuffing orchewing tobacco. However, smoking has, as earlier mentioned, healthhazards and it is therefore desirable to formulate an alternative mannerof administering nicotine in a pleasurable manner that can be used tofacilitate withdrawal from smoking and/or used as a replacement forsmoking.

[0011] Upon the smoking of a cigarette, nicotine is quickly absorbedinto the smoker's blood and reaches the brain within around ten secondsafter inhalation. This quick uptake of nicotine gives the consumer arapid satisfaction, or kick, and this satisfaction lasts during thesmoking time of the cigarette and for a period of time thereafter. Thepoisonous, toxic, carcinogenic, and addictive nature of smoking hasprovided efforts for methods, compositions and devices, which help inbreaking the habit of smoking cigarettes.

[0012] Nicotine Replacement Products

[0013] One way to reduce smoking is to provide nicotine in a form ormanner other than by smoking and some products have been developed tofulfill this need. Use of such nicotine-containing formulations iscurrently the dominating treatment for tobacco dependence.

[0014] The present successes in achieving reduction in the incidence ofsmoking have been relatively poor using presently known products. Thepresent state of the art involves both behavioral approaches andpharmacological approaches. More than 80 % of the tobacco smokers whoinitially quit smoking after using some behavioral or pharmacologicalapproach to singly reduce smoking incidence generally relapse and returnto the habit of smoking at their former rate of smoking within about aone year's period of time.

[0015] As an aid for those who are willing to stop smoking there areseveral ways and forms of nicotine replacement products available on themarket and several methods and means have been described for diminishingthe desire of a subject to use tobacco, which comprises the step ofadministering to the subject nicotine or a derivative thereof asdescribed in e g U.S. Pat. No. 4,967,773 (nicotine containing lozenge)and U.S. Pat. No. 5,939,100 (nicotine containing microspheres).

[0016] The use of skin patches for transdermal administration ofnicotine has been reported (Rose, in Pharmacologic Treatment of TobaccoDependence, (1986) pp. 158-166, Harvard Univ. Press).Nicotine-containing skin patches, which are in wide use today, may causelocal irritation and the absorption of nicotine is slow and affected bycutaneous blood flow. Different types of such patches are also patented,see e.g. U.S. Pat. No. 4,915,950 and U.S. Pat. No. 4,597,961.

[0017] Nicotine-containing nose drops have been reported (Russell etal., British Medical Journal, Vol. 286, p. 683 (1983); Jarvis et al.,British Journal of Addiction, Vol. 82, p. 983 (1987)). Nose drops,however, are difficult to administer and are not convenient to use atwork or in other public situations. Ways of administrating nicotine bydelivering directly into the nasal cavity by spraying are known fromU.S. Pat. No. 4,579,858, DE 32 41 437 and WO 93/12764. There may,though, be local nasal irritation with use of nasal nicotineformulations. The difficulty in administration also results inunpredictability of the dose of nicotine administered.

[0018] Nicotine mouth sprays (see e.g. U.S. Pat. No. 6,024,097 and U.S.Pat. No. 5,810,018) and nicotine chewing gums (see e.g. U.S. Pat. No.3,845,217) are also known.

[0019] Also, inhaling devices resembling a cigarette are known foruptake of nicotine vapors orally as suggested in U.S. Pat. No.5,167,242, wherein the inhaling device contains a nicotine reservoir.The present invention relates primarily, but not exclusively, to a noveland inventive improvement of the nicotine reservoir (plug) disclosed inU.S. Pat. No. 5,167,242.

[0020] Prior Art and Problems Thereof

[0021] One embodiment of the inhaling device disclosed in U.S. Pat. No.5,167,242 comprises a cylindrical cartridge in which is placed anicotine reservoir. Such a reservoir consists of a porous plug made ofpolymer or other suitable material, which is loaded with nicotine.Suitable materials for such a plug are e.g. those mentioned in U.S. Pat.No. 4,284,089, U.S. Pat. No. 4,800,903 and U.S. Pat. No. 4,813,437 e.g.polymeric material containing polyolefin, polyethylene, polypropylene,polybutadiene, poly-1-butene, polyisobutylene, polyisoprene,poly-4-methyl-1-pentene or combinations thereof, a fibrous materialwhich may comprise cellulose-acetate polypropylene, polyester,polyethylene and combinations thereof. The above-mentioned porous plugsare manufactured through a sintering process. U.S. Pat. No. 4,793,366discloses a device for inhaling nicotine with a “draw” similar to thatof a conventional cigarette—though without showing that such a “draw”may be obtained with the claimed device. U.S. Pat. No. 5,101,838discloses a device for smoking simulation where the carrier for nicotinepreferably is made of spherical particles. U.S. Pat. No. 5,167,242, U.S.Pat. No. 4,284,089, U.S. Pat. No. 4,800,903, U.S. Pat. 4,813,437, U.S.Pat. No. 4,793,366 and U.S. Pat. No. 5,101,838 are hereby incorporatedby reference.

[0022] The presently known porous nicotine containing plug releasesnicotine to the air sucked through it by the user when the user puff onthe inhaling device. However, it has now been found that the user doesnot inhale enough nicotine per puff (Schneider et al.; Clin.Pharmacokinetics 2001; 40 (9) 661-684 and Russel; British J. ofAddiction (1991) 86, 653-658) in order to experience completesatisfaction. Therefore the user must puff intensively in order toachieve a basal, but oftentimes still non-sufficient, concentration ofdrug (Schneider et al.; Clin. Pharmacokinetics 2001; 40 (9) 661-684).Hence, such an inhaling device often does not sufficiently wellcounteract the craving experience by the tobacco addict, who thereforeis likely to relapse to use of tobacco. To date no solution to theproblem of the user not inhaling enough nicotine per puff has beenpresented.

[0023] Definitions

[0024] The term “nicotine” is intended to include nicotine,3-(1-methyl-2-pyrrolidinyl)-pyridine, with its base form, racemic form,R- and S-forms, including synthetic nicotine as well as nicotineextracts from tobacco plants, or parts thereof, such as the genusNicotiana alone or in combination; or pharmaceutically acceptable salts.

[0025] The term “container comprising nicotine”, or equivalent terms, isintended to include a nicotine reservoir loaded with nicotine that willallow air to pass through and that will deliver nicotine in gaseous orliquid aerosol form to a subject.

[0026] The term “fast reduction of the urge to smoke or use tobacco” isherein intended to mean an initial priming of the subject so as toachieve a reduction of the urge to smoke or use tobacco.

[0027] The term “complete reduction” is herein intended to mean completeor substantially complete reduction.

[0028] The terms “fibers” and “filaments” are intended to mean any ofthe thread-like parts that are formed from plant and/or artificialmaterial with arbitrary cross sections.

[0029] The term “tobacco-containing material” may be material used for eg smoking, snuffing or chewing and may comprise a cigarette, a cigar,snuff, pipe tobacco and chewing tobacco.

[0030] The term “shaped mass” is intended to mean a mass of materialdeliberately shaped.

SUMMARY OF THE INVENTION

[0031] The present invention is intended to solve the above-mentionedproblem, i.e. that the user does not receive enough nicotine per puff toexperience satisfaction. We have however found that said problemcouldn't be solved by increasing the amount of nicotine in the containersince the air inhaled with the existing device is already saturated withnicotine and hence cannot be loaded with more nicotine. In the presentinvention we have surprisingly found said problem is solved byincreasing the volume of air inhaled per puff thereby increasing theamount of nicotine being inhaled per puff—this being achieved by using anicotine container comprising a shaped mass of fibers or filaments.

[0032] The main object of the present invention is thus to provide acontainer comprising nicotine and a shaped mass of fibers or filaments,which is able to reversibly retain and release nicotine. This containerallow a larger amount of air being inhaled per puff and also providethat the air is inhaled with less efforts compared to theabove-mentioned presently known plugs. The flow resistance through thepresent container is thus lower than the flow resistance through theexisting plugs. It has also been found that with the present inventionthe flow resistance may be lowered to below a half, and even below afourth, of the flow resistance of presently used plugs in nicotineinhalers. The air passing through the container is adequately saturatedwith nicotine in spite of the low airflow resistance.

[0033] The present invention also provides a method for obtainingreduction of the urge to smoke or use tobacco containing material and/orfor providing a fast sense of smoking satisfaction without smoking,comprising the steps of replacing at least partly the tobacco containingmaterial used with an inhaling device that comprises the above-mentionedcontainer comprising nicotine.

[0034] Furthermore, the present invention also provides a system fordelivering nicotine to a subject, which comprises said containercomprising nicotine and at least one other means for obtaining reductionof the urge to smoke or use of tobacco and a system for obtainingreduction of the urge to smoke or otherwise use of tobacco and/or forproviding a sense of smoking satisfaction without smoking, comprisingsaid container comprising nicotine and at least one other method forobtaining reduction of the urge to smoke or otherwise use of tobacco.Said system may be a system wherein the at least one other method isselected from the group consisting of administration through chewinggums, nasal sprays, transdermal patches, mouth sprays, lozenges, tabletsand parenteral methods, subcutaneous methods, intravenous methods,rectal methods, vaginal methods and transmucousal methods; or otherwiseuse of tobacco.

[0035] The present invention also relates to the use of said productthat will according to the invention rapidly deliver nicotine to asubject and also to the use of the present invention for obtaining aquick and/or sustained and/or complete reduction of the urge to smoke oruse tobacco and/or for providing a sense of smoking satisfaction withoutsmoking resembling the sense of smoking satisfaction and/or forobtaining a reduction of the urge to smoke obtained after regularsmoking or use of tobacco.

DETAILED DESCRIPTION OF THE INVENTION

[0036] In one embodiment said container comprising nicotine has fibersor filaments that comprise polymeric substances. The polymericsubstances may be selected from polyolefin, polyester or polyamide andare preferably selected from the group consisting of polyethylene,polyethylene, preferably high-density polyethylene or ultra highmolecular weight polyethylene, polypropylene, polybutadiene,poly-1-butene, polyisobutene, polyisoprene, polyvinylidene chloride,ethylene vinyl alcohol, polylactide-glycolide copolymer, polycarbonate,polyethylene naphthalene, polytrimethylene naphthalene, polyethyleneterephthalate, terephthalate-isophthalate polyesters, polybutyleneterephthalate, liquid crystalline polymer that comprises hydroxy benzoicacid and hydroxy naphtenic acid, a copolymer of acrylonitrile andmethacrylate grafted to nitrile rubber, which is commercially availableunder the trademark Barex®, nylon 66, or nylon 6 or combinations thereofand paper, cellulose and/or cloth. Preferably the fibers or filamentsare non-sintered. The container may though comprise also non-sinteredmaterial. The fibers or filaments may comprise also non-polymericmaterials, such as glass, metals, e g aluminum and/or steel. The fibersor filaments may optionally be coated.

[0037] The container may also comprise non-fibrous material. Preferablythe shaped mass of fibers or filaments is non-sintered. The containermay though comprise also non-sintered material. The shaped mass offibers or filaments may comprise non-polymeric material, such as glass,metals, e g aluminum and/or steel, paper, cellulose and/or cloth.

[0038] A preferred type of fibers or filaments is made of polyethyleneterephtalate, preferably covered with copolyolefin.

[0039] The fibers or filaments may be manufactured in a number ofdifferent ways known in the art, such as through extrusion and spinning.

[0040] Preferably the container should have a flow resistance of gasbeing lower than around 0,6 kPa, more preferably lower than around 0,3kPa at an airflow rate of 1000 ml/min.

[0041] The nicotine is preferably retained to the shaped mass of fibersor filaments by chemical binding and/or by adsorption and/or byabsorption and released by breaking these mechanisms. The absorptionand/or adsorption processes, which release nicotine may further beelectrically enhanced and/or modified by temperature.

[0042] The container is for use in a nicotine-inhaling device, which isadapted to be received in the mouth or in the nose.

[0043] The container should preferably be encapsulated in such a waythat nicotine will not unintentionally migrate out from the containerand so that environmental oxygen will not enter the container. For suchencapsulation of the container a nicotine-impermeable copolymer made ofacrylonitrile and methacrylate and grafted to nitrile rubber can beused, said copolymer being commercially available under the trademarkBarex®. Polyethylene naphtalate, known under the name PEN, and/or aliquid crystalline polymer comprising hydroxy benzoic acid and hydroxynaphtenic acid, known under the name Vectra® A530, can also be used forsuch encapsulation. Optionally said polymers can be laminated, e g withaluminum layer. Preferably said encapsulation should be made in anoxygen-free environment. Upon use of the container the encapsulation isbroken in order for the user to inhale through the container. Saidencapsulation is essence is done according to the disclosure of theabove-mentioned patent U.S. Pat. No. 5,167,242.

[0044] Methods of Production

[0045] One preferred embodiment of loading the containers with nicotineis to let a gas comprising nicotine pass through the containers thusallowing the nicotine to be absorbed and/or adsorbed by the material ofthe container.

[0046] Another preferred embodiment of loading the containers withnicotine is immersing the containers into a solution comprising nicotinein its free base form. Preferably the solvent is an organic solvent,preferably an organic solvent having a low boiling point and being morevolatile than nicotine, more preferably an organic solvent beingselected from the group of ethers, ketons and alcohols, even morepreferably being an organic solvent being selected from alcohols, andmost preferably being ethanol.

[0047] Still another preferred embodiment of loading the containers withnicotine is to inject a solution comprising nicotine, with e.g. asyringe, in the containers.

[0048] The containers may also be loaded with nicotine by spraying orsoaking or immersing the fibers or filaments with nicotine or with anicotine-containing liquid directly upon the fibers or filaments, andthe optional non-fibrous material, having been manufactured, e g uponthem having been extruded or spun, prior to the fibers or filamentsbeing formed to a shaped mass. The same loading principle could beapplied if the containers optionally comprise also non-fibrous material.

[0049] Different additives may optionally be added to the containers, eg one or more stabilizing additives, such as those selected from thegroup consisting of antioxidants including vitamin E, i.e. tocopheroles,vitamin C, i.e. ascorbic acid, sodium pyrosulfite, butylhydroxytoluene,butylated hydroxyanisole; and preservatives including parabenes, citricacid, tartaric acid, lactic acid, malic acid, acetic acid, benzoic acid,and sorbic acid; and chelating agents, such as EDTA; and galates, suchas propyl galate.

[0050] Further optional additives can comprise one or more additivesselected from the group consisting of enhancers, such as azone,vitamins, such as vitamins B, C and E, minerals, such as fluorides,especially sodium fluoride, sodium monofluoro phosphate and stannousfluoride, anti-odors, such as zinc and cyclodextrins, propellants, suchas 1,1,2,2-tetrafluoroethane (HFC-134a), optionally being liquefied, and1,1,1,2,3,3,3-heptafluororpropane (HFC-227), optionally being liquefied,sweeteners including one or more synthetic or natural sugars, such asthose selected from the group consisting of artificial sweeteners suchas saccharin, sodium saccharin, aspartame, e g NutraSweet, acesulfame oracesulfame K (also called potassium acesulfame), thaumatin andglycyrrhizin; sugar alcohols, such as sorbitol, xylitol, single sugarsincluding sugars extracted from sugar cane and sugar beet (sucrose),dextrose (also called glucose), fructose (also called laevulose), andlactose (also called milk sugar); mannitol, glycerol; and mixtures ofsugars including glucose syrup, e g starch hydrolysates, containing amixture of dextrose, maltose and a range of complex sugars, invert sugarsyrup, e g sucrose inverted by invertase (also called sucrase orsacchrase) containing a mixture of dextrose and fructose, high sugarcontent syrups such as treacle and honey containing a mixture ofparticularly laevulose, dextrose, maltose, lactitole, sucrose, resins,dextrin and higher sugars; and malt or malt extracts; and mixturesthereof.

[0051] Flavor and aroma additives can also be added. These may compriseone or more synthetic or natural flavoring or aromatizing agents. Flavorand aroma agents may be selected from the group comprising essentialoils and preparations thereof including distillations, solventextractions, or cold expressions of chopped flowers, leaves, peel orpulped whole fruit comprising mixtures of alcohol, esters, aldehydes andlactones; essences including either diluted solutions of essential oils,or mixtures of synthetic chemicals blended to match the natural flavorof the fruit, e g strawberry, raspberry and black currant; artificialand natural flavors of brews and liquors, e.g. cognac, whisky, rum, gin,sherry, port, and wine; tobacco, coffee, tea, cocoa, and mint; fruitjuices including expelled juice from washed, scrubbed fruits such aslemon, orange, and lime; spear mint, pepper mint, wintergreen,cacoe/cocoa, vanilla, liquorice, menthol, eucalyptus, aniseeds, nuts,e.g. peanuts, coconuts, hazelnuts, chestnuts, walnuts, cola nuts;almonds, raisins; barks, e.g. cinnamon, roots, e.g. ginger, and mixturesthereof.

[0052] The nicotine should be in gaseous or liquid aerosol form wheninhaled in order to facilitate the absorption and uptake anywhere in themouth or oral cavity and/or the upper respiratory tract and/or lungs.

[0053] The nicotine may act as a substituted stimulant e.g. to obtain arapid reduction of the urge to smoke or to use tobacco. The effect maybe to provide a sense of smoking satisfaction without smoking. Anothereffect of the administered nicotine may be a reduction of the urge tosmoke or use tobacco.

[0054] The effect may also be a combination of reduction of said urgeand providing a sense of smoking satisfaction without smoking. Theamount of the nicotine should be sufficient to provide such an effect ina subject. This amount may, of course, vary from person to person.

EXAMPLE 1

[0055] Process for the manufacturing of nicotine-comprising containerswith 15 mg nicotine/container for use with inhaling devicesManufacturing formula: Batch size: 100 000 units Formula: Loadingsolution: Nicotine 1 545 g Levomenthol 150 g Ethanol* 16 000 g Loadingof containers: Containers from a shaped mass of 100 000 pieces fibers orfilaments of polyethylene terephtalate covered with a copolyolefinsheath. Loading solution 17 695 g Nitrogen q.s. Assembly:Nicotine-loaded containers 100 000 pieces Plastic cartridges made ofBarex ® 100 000 pieces Barex ®-coated aluminum foil q.s. Nitrogen q.s.

[0056] The manufacturing phases were:

[0057] Loading solution:

[0058] Levomenthol and nicotine were dissolved in ethanol.

[0059] Loading of containers:

[0060] The containers were added to a vacuum cone blender. The loadingsolution was added to a blender and the containers were mixed with theloading solution. A vacuum was applied and the temperature was increasedto about 50° C. in order to remove ethanol. The drying process wasterminated by cooling the jacket of the blender. The nicotine-loadedcontainers were transferred to airtight bulk containers, which wereevacuated and filled with nitrogen.

[0061] Assembly and sealing:

[0062] The assembly of the nicotine-loaded containers into the plasticcartridges was performed in separated zones, involving feeding of thecontainers and cartridges from a first zone, and the subsequent assemblyin a second zone. Sealing of the plastic cartridges was made by weldingwith Barex®-coated aluminum foil. All zones were separately fed withnitrogen.

[0063] Method for Delivering Nicotine to a Subject

[0064] According to the invention, a method for delivering nicotine to asubject comprises the steps of

[0065] a) administering to a subject air loaded with nicotine by usingan inhalation device containing the container comprising nicotine and

[0066] b) allowing the nicotine to be released in the mouth/oral cavityand/or the upper respiratory tract and/or the lungs and then beingabsorbed into the blood plasma of the subject.

[0067] Method for Obtaining Reduction of the Urge to Smoke or Use ofTobacco

[0068] A method for obtaining reduction of the urge to smoke or usetobacco-containing material and/or for providing a sense of smokingsatisfaction without smoking according to the invention comprises thesteps of:

[0069] a) replacing at least partly the tobacco containing material withan inhaling devise comprising the container comprising nicotine,

[0070] b) administering to a subject nicotine according with the help ofthe container comprising nicotine into the oral cavity and/or the upperrespiratory tract and/or the lungs of the subject, and

[0071] c) allowing the nicotine to be absorbed by the subject.

[0072] The administration of nicotine takes place by the subjectinhaling air loaded with nicotine i.e. the subject puffs on the inhalercomprising the container comprising nicotine as the air passes saidcontainer the nicotine is released from said container and the subjectwill thus receive air loaded with nicotine. The administration isessentially intended for the mouth/oral cavity and/or the upperrespiratory tract and/or the lungs.

[0073] Even further embodiments of the method for delivering nicotine toa subject may comprise the steps of combining the method of using thepresent inhaling device with at least one other method for obtainingreduction of the urge to smoke or use of tobacco.

[0074] The container comprising nicotine may be used for obtaining aquick and/or sustained and/or complete reduction of the urge to smoke oruse of tobacco and/or for providing a sense of smoking satisfactionwithout smoking as further discussed below. The fast relief provides thesubject with a sense of rapid smoking satisfaction without smoking.

[0075] Systems for Delivering Nicotine and for Obtaining Craving Relief

[0076] According to the present invention is also provided a system fordelivering nicotine to a subject. Such a system comprises the containercomprising nicotine according to the present invention and an inhalationdevice, and at least one other means for obtaining reduction of the urgeto smoke.

[0077] Another system according to the invention may also be a systemfor obtaining reduction of the urge to smoke or use of tobacco and/orfor providing a sense of smoking satisfaction without smoking. Such asystem comprises the container comprising nicotine according to theinvention and at least one other means for obtaining reduction of theurge to smoke or use tobacco. Other means/methods may also be aconcomitant or concurrent method selected from the group consisting ofadministration through nasal sprays, transdermal patches, lozenges,tablets and parenteral methods, subcutaneous methods, intravenousmethods, rectal methods, vaginal methods and transmucosal methods; oruse of tobacco.

[0078] In a specific embodiment, the at least one other method/methodcomprises administration of nicotine.

[0079] Use of the Container Comprising Nicotine

[0080] The use of the container comprising nicotine according to theinvention for obtaining a fast and/or sustained and/or completereduction of the urge to smoke and use tobacco or for providing a senseof smoking without smoking as described above.

[0081] The dose of the nicotine is chosen to give the subject anindividual sensory perception and nicotine satisfaction. The use of thecontainer comprising nicotine according to the invention may also be asole use according to the invention or a combination with other means ormethods known in the field of drug abuse. Specifically, the presentinvention may be used in combination with other means as described abovein the methods in the paragraphs above. The use may give a quickreduction of the urge to smoke or use tobacco.

1. A container comprising a shaped mass of fibers and/or filaments; andnicotine releasable retained in said shaped mass.
 2. The containeraccording to claim 1, wherein said container has a flow resistance ofgas being lower than the equivalent of about 1.0 kPa at a gas flow rateof about 1000 ml/min.
 3. The container according to claim 1, whereinsaid container has a flow resistance of gas being lower than theequivalent of about 0.6 kPa at a gas flow rate of about 1000 ml/min. 4.The container according to claim 1, wherein said container has a flowresistance of gas being lower than the equivalent of about 0.3 kPa at agas flow rate of about 1000 ml/min.
 5. The container according to claim1, wherein said nicotine is retained by means selected from the groupconsisting of chemical binding, adsorption, absorption or mixturesthereof, and released by breaking these mechanisms.
 6. The containeraccording to claim 1, wherein said container further comprisesnon-fibrous material.
 7. The container according claim 1, wherein saidfibers or filaments are non-sintered.
 8. The container according toclaim 1, wherein said container further comprises sintered material. 9.The container according to claim 1, wherein said fibers or filamentscomprise a member selected from the group consisting of glass, metals,paper, cellulose, or cloth.
 10. The container according to claim 9,wherein said fibers or filaments comprise aluminum or steel.
 11. Thecontainer according to claim 1, wherein said fibers or filamentscomprise polymeric material.
 12. The container according to claim 11,wherein said polymeric material comprises a member selected from thegroup consisting of polyolefin, polyester and/or polyamide.
 13. Thecontainer according to claim 12, wherein said polymeric materialcomprises comprises a member selected from the group consisting ofpolyethylene, polypropylene, polybutadiene, poly-1-butene,polyisobutene, polyisoprene, polyvinylidene chloride, ethylene vinylalcohol, polylactide-glycolide copolymer, polycarbonate, polyethylenenaphthalene, polytrimethylene naphthalene, polyethylene terephthalate,terephthalate-isophthalate polyesters, polybutylene terephthalate,liquid crystalline polymer that comprises hydroxy benzoic acid andhydroxy naphtenic acid, a copolymer of acrylonitrile and methacrylatenylon 66, or nylon 6 or copolymers thereof or combinations thereof. 14.The container according to claim 13, wherein said polymeric materialcomprises polyethylene.
 15. The container according to claim 13, whereinsaid polymeric material comprises polyethylene terephtalate.
 16. Thecontainer according to claim 1, wherein said fibers or filaments areproduced by spinning and/or extrusion.
 17. The container according toclaim 5, wherein said retaining and/or release of nicotine iselectrically enhanced and/or modified by temperature.
 18. A method forproducing a container according to claim 1, wherein said container isloaded with nicotine by using a gas that comprises nicotine.
 19. Themethod according to claim 18, wherein said loading is done in anoxygen-free environment.
 20. The method for producing a containeraccording to claim 1, wherein said container is loaded with nicotine byimmersing said container in a solution comprising nicotine.
 21. Themethod according to claim 20, wherein said loading is done in anoxygen-free environment.
 22. The method according to claim 20, whereinsaid solution used for loading comprises nicotine and an organicsolvent.
 23. The method according to claim 22, wherein said organicsolvent is selected from organic solvents that are more volatile thannicotine.
 24. The method according to claim 23, wherein said organicsolvent is selected from the group of ethers, ketones and alcohols. 25.The method according to claim 24, wherein said organic solvent isselected from alcohols.
 26. The method according to claim 25, whereinsaid organic solvent is ethanol.